MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10013365
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the white part below the spike of the device separated from the clear part where it was intended to be bonded.The nurse was setting up a chemotherapeutic infusion in a pump and it separated when hung.The nurse was exposed, took a shower, donned new clothing and went to the employee health.There was no patient or staff harm.
Event or Problem Description
The customer reported that the white part below the spike of the device separated from the clear part where it was intended to be bonded.The nurse was setting up a chemotherapeutic infusion in a pump and it separated when hung.The nurse was exposed, took a shower, donned new clothing and went to the employee health.There was no patient or staff harm.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of spike separated was confirmed.The customer¿s photo was evaluated and the reported event of spike separation was observed to be from the drip chamber spike to the port spike.The root cause of this failure was not identified as no product was returned.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8143577
• Report Number: 9616066-2018-02380
• Device Sequence Number: 1887324
• Product Code: FPA
• UDI-Device Identifier: 07613203010412
• UDI-Public: 7613203010412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: 10013365
• Device Catalogue Number: 10013365
• Device Lot Number: 18068023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8100, TD UNK